The present invention relates to filling sterile delivery devices, such as syringes, and more particularly to a method and apparatus for automatically producing a plurality of prebilled, sterile delivery devices.
In the pharmaceutical industry, most hospitals have pharmaceutical compounding facilities. The pharmacists or technicians that work in the compounding facilities are often required to undertake manually intensive processes for filling plastic syringes with medicaments. Such medicaments are typically supplied to the pharmacists in one of two forms.
In the first form, the pharmacist receives 10 to 100 vials of dry, powdered medicament. Each vial includes a bottom having a periphery and a wall extending generally upwardly from the periphery. The container bottom and container wall define an interior container portion which receives the powdered medicament. The container wall extends upwardly to form a shoulder and a neck portion. The neck portion has an opening which receives a vial septum for sealing the opening and providing access to the interior container portion by piercing the vial septum with a needle, in a manner well understood by those of ordinary skill in the art.
It is the technician's responsibility to reconstitute the powdered medicament in the vial and transfer the reconstituted medicament to a sterile IV bag or bottle from which the reconstituted medicament can be dispensed, such as with a syringe or IV drip application. The technician places as many as 10 to 100 vials containing the powdered medicament into a laminar flow hood. A peristaltic pump with one set of transfer tubing and a container of sterile liquid, such as water, are placed under the laminar flow hood. The pump is used to transfer the sterile liquid from the container into the vials for the purpose of reconstituting the powdered medicament. The technician connects one end of the transfer tubing set between the pump and the container of sterile liquid. For instance, where the container of sterile fluid is an IV bag, the spike end of the transfer tubing is connected to the IV bag. The other end of the transfer tubing set extends between the pump and a Luer lock connector to which is attached a transfer needle.
To reconstitute the dry, powdered medicament within the vial, the technician pierces the vial septum of the vial with the transfer needle and then manually actuates the pump to begin transferring the sterile liquid from the sterile liquid container to the vial. When the pump is actuated, it automatically dispenses a preprogrammed amount of sterile liquid into the vial. Once the predetermined amount of sterile liquid is transferred to the vial, the pump automatically ceases operation. At this point, the technician removes the needle from the vial septum and inserts it into another vial septum of a vial having dry, powdered medicament therein and actuates the pump. The vial which has been filled with the predetermined amount of sterile liquid is then shaken to thoroughly mix the powdered medicament and the sterile liquid. This process is carried out for each of the 100 vials until they all have been reconstituted.
Once the powdered medicament in the vials has been reconstituted, it is then necessary to transfer the reconstituted powdered medicament to an IV bag or vacuum bottle for dispensing the reconstituted medicament to a syringe. First the pharmacy compounding technician must place the vials and an empty IV bag or vacuum bottle under the laminar hood for the transfer process. One end of transfer tubing is then connected between the pump and the empty IV bag or vacuum bottle by using the spike end of the transfer tubing to access the empty IV bag or vacuum bottle. The other end of transfer tubing is connected to the pump and at its distal end includes a Luer lock connector to which the technician attaches a transfer needle.
The technician then transfers the reconstituted powdered medicament within each vial to the sterile IV bag or vacuum bottle. This process is accomplished by having the technician hold an inverted vial in one hand while the other hand pierces the vial septum with the transfer needle. The technician then turns on the pump to extract the reconstituted powdered medicament from the vial. As the reconstituted powdered medicament is being transferred from the vial, the technician must be careful to draw all of the reconstituted powder medicament and therefore must locate the tip of the transfer needle just on the other side of the vial septum. Once the entirety of the reconstituted powder medicament is withdrawn from the vial, the technician must turn the pump off manually. This process is repeated for all 100 vials until all of the reconstituted powdered medicament has been transferred to one or more empty IV bags or vacuum bottles. The reconstituted powdered medicament is then transferred from the IV bags or bottles to sterile delivery devices as described below.
In the second form, the pharmacist receives 10 to 100 vials or containers of hydrated medicament which must be transferred to the sterile delivery devices. Thus, in the second form the step of reconstituting the dry, powdered medicament is avoided, but the hydrated medicament is then transferred to the sterile delivery devices using a two-step procedure. The use of the term "sterile delivery device" refers to any mechanical element used for delivering a sterile parenteral medicament. A typical sterile delivery device is a syringe. Syringes are provided in many different sizes, shapes and forms. Typically, the syringe includes a hollow barrel with a dispensing nozzle at one end and an open opposite end. A piston plunger is positioned within the open end and is slidable in sealing engagement with the barrel to retain a fluid therein. A hypodermic needle or other transfer device is secured to the dispensing nozzle in any of a number of ways, such as with a Luer lock.
The first step of the procedure is identical to that described above in connection with transferring the reconstituted powdered medicament within each vial to the sterile IV bag or vacuum bottle. The second step requires the technician to transfer the hydrated medicament in the large container (i.e. IV bag or vacuum bottle) to individual syringes which are then stored in an appropriate medium, such as a freezer, until it is time to administer the medicament. The technician can use a variety of methods to transfer the fluid from the container to the sterile delivery device. One method simply requires the pharmacist to place a tube between the container and the dispensing nozzle of the sterile delivery device, and then by pulling on the plunger the hydrated medicament is withdrawn from the container, through the tube and into the sterile delivery device.
Another method involves the use of a peristaltic pump and transfer device. In this method, the container of hydrated medicament is connected to the suction side of the pump using one end of the transfer tubing set. A transfer device is connected to the discharge side of the pump using the other end of the transfer tubing set. The transfer device may be in the form of a simple block having appropriate conduits such that the tubing leading from the discharge side of the pump feeds the hydrated medicament from the pump through the block to a female Luer lock connector. In use, the technician inverts a sterile delivery device with the male Luer lock dispensing nozzle receiving the female Luer lock connector from the transfer device in a sealed manner. The technician then actuates the pump which then transfers the fluid from the container to the sterile delivery device causing the plunger of the sterile delivery device to move upward until the pump automatically shuts off when a predetermined amount of the hydrated medicament has been transferred to the sterile delivery device. This process is repeated until the hydrated medicament is exhausted from the bag or until a desired number of sterile delivery devices have been filled.
As is apparent from the foregoing description, the process of filling the sterile delivery devices is labor intensive. This is even more apparent where the technician must hydrate one hundred vials of dry, powdered medicament and then transfer the hydrated medicament to sterile delivery devices.
Attempts have been made to improve upon the foregoing manual methods by providing prebilled sterile delivery devices. However, previous methods of filling sterile delivery devices involved filling the sterile delivery devices from the end of the sterile delivery device which receives the piston plunger. This method exposes the hydrated medicament to the atmosphere. Thus, risking the entry of microbial contaminants into the hydrated medicament. To minimize this risk, these previous methods of prefilling sterile delivery devices require that extensive steps be taken to ensure the transfer of the hydrated medicament in a sterile manner.
The present invention overcomes many of the disadvantages inherent in the above-described methods of prefilling sterile delivery devices by providing an apparatus which can automatically fill sterile delivery devices in a sterile manner without the necessity of requiring extensive steps be taken to prevent entrance of microbial contaminants into the hydrated medicament. The present invention fills the sterile delivery devices through the dispensing nozzle to minimize the risk of the hydrated medicament being exposed to atmosphere. Moreover, the present invention provides an automated method and apparatus for prefilling the sterile delivery devices which results in considerable savings in time and money as compared to the conventional methods of filling sterile delivery devices.